Condoms are devices that are used for both contraception and protection during sexual intercourse against the transfer of infectious matter such as bacterial and viral microbes that cause venereal diseases. The continued increase in the incidences of HIV/AIDS has caused various health organizations to encourage people to increase the use of condoms during sexual intercourse in or to prevent the further spread of the disease.
Condoms comprise a thin tubular casing that is typically manufactured from natural rubber latex and that has an open end and a closed end. Traditional condoms are drawn over the penis before coitus. The casing of the condom has an inner diameter that is selected so that the condom fits tightly on the penis. At the open end of a condom an elastic, flexible ring or rolled portion of latex is usually provided. This ring portion is generally the same diameter as the tubular casing of the condom. This elastic ring portion serves primarily to secure the condom on the penis and to prevent leakage of semen for the interior of the condom. These elastic ring portions of a condom do not radially extend the open end of the condom. Indeed, the rings do not supply enough rigidity to alter the shape of the condom.
It is generally accepted that HIV/AIDS can only be transferred through contact with the carrier's bodily fluid. During sexual intercourse such a transfer of HIV/AIDS occurs when skin lesions of the carrier contact the mucous membrane or skin of the carrier's partner or through transfer of the carriers semen. Such a transfer of HIV/AIDS may occur at the base of the penis and at the vulva. There is a risk that lesions in these areas can be caused to bleed during sexual intercourse. When using a standard condom, these areas are unprotected or unshielded by the condom, and consequently a condom does not offer full protection against the transfer of infectious matter such as HIV/AIDS.
Numerous attempts have been made to design a condom or condom-like device that provides effective contraception and/or more protection against the transfer of infectious matter than the standard condom. A sampling of these attempts are described below.
An article, “Outline For Successful Prophylactic Program” (Waterbury, Conn.: The Hemingway Press, 1934), the Gee Bee Company, 7-16, discloses a prophylactic device entitled, “The Gee Bee.” This device is a loose fitting tubular prophylactic having a grooved outer ring. The grooved outer ring does not form a collar-shaped, outwardly extending portion at the open of the prophylactic. This invention does not disclose any description of a “female” embodiment having a means for retaining the closed end of the device in the vagina.
German Patent Number 210,413 to Hollmann discloses a condom-like device having an outer ring. The outer ring of this invention radially extends the opening of the condom. This invention has no means for retaining the closed end of the device in the vagina.
U.S. Pat. No. 899,251 to Graham discloses an animal breeder's bag. The bag is a condom-like device for livestock that can be used to collect semen. The bag contains a fixed inner band that is positioned at about the middle of the device. This position for the attachment of the band provides for a tube and a bag-like extension. The purpose of the band and cross strips is to collect semen in a pocket. A rubber frame can be made in various shapes, but is not disclosed as forming a collar-shaped, outwardly extending portion at the opening off the prophylactic. The band of this device is designed and positioned on the device in order to provide a semen collection bag. The band does not have a structure that is located at the closed end of the device to provide a retaining means such as is required for a “female condom”.
U.S. Pat. No. 4,004,591 to Freimark discloses a birth control device. This birth control device is a female condom made of a strong rubber, plastic, or other similar material. This condom has a rigid, ring-like rim that is bent or scalloped. This rim can be a wire. The rim is not adapted to radially extend the open end of this device because this device is a hard molded material and not flexible. The cross-sectional dimensions of this condom are disclosed as being sufficiently large to easily accommodate the average width of the penis with some additional clearance space. The primary function of this device is to prevent unwanted pregnancy. This device is useful in preventing the spread of venereal disease. This device provides no means at the vulva to prevent an exchange between partners of secreted fluids that can contain infectious agents. Additionally, this birth control device is intended for use by females, but includes no means to secure or maintain the device in the vagina.
U.S. Pat. No. 4,630,602 to Strickman et al. discloses a disposable contraceptive cervical barrier. The cervical barrier of this invention is similar to standard diaphragms in size and design. This cervical barrier contains various “cavities for cells” that can hold spermicidal lubricants. These spermicidal lubricants can also be placed in numerous grooves within the body of the cervical barrier. Urethane polymers are used to make the device. The cervical barrier of this invention, unlike a condom, has no tubular side walls to prevent the exchange of secretion between partners that can contain a venereal disease.
Retained sheaths or “female condoms” have been sold for some time. One type of such a device is disclosed in the Hessel et al. patents, U.S. Pat. Nos. 4,735,621, 4,976,273, 5,094,250, 5,490,519, and 5,623,946. In the principle embodiment discussed in these patents, the urethane ring at the open end of the tubular member is a separate unit from the urethane sheath itself. The sheath is then attached to the ring through for example a welding step. The Hessel patents also discuss that the ring can be formed by rolling the polymer material that forms the walls of the tubular structure from the open end, so as to form a ring of material. This ring of material can then be kept from unrolling by heating or using an adhesive.
The Hessel patents while they mention use of natural rubber latex, never address the problems associated with such a construction. Specifically, while rolling a ring is theoretically possible it presents many challenges. Typical polymer materials used in the construction of contraceptive barriers (i.e., natural rubber latex or polyurethane) will rip upon rolling or are too sticking to be effectively rolled. Often when a material is rolled into a bead of sufficient size, air or moisture is captured in the bead and upon drying the air expands and moisture boils resulting in a rupture in the bead.